510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,486 records, page 390 of 1190
FDA device recalls, page 390 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0275-2020Class IICTSTM Essential 8 MediumLife Technologies CorporationN/A
Z-0274-2020Class IIStemPro MSC SFM CTS"Life Technologies CorporationNDS
Z-2150-2019Class IIHuman Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is...Randox Laboratories, LimitedJJY
Z-2354-2019Class IILuer Lock Set - Catalog # MPC-125, for IV administration sets.Molded Products IncFPA
Z-2363-2019Class IIAlinity ci -series System ControlModule, Part Number 03R70 01 Product Usage: The Alinity...Abbott MedicalJJE
Z-2011-2019Class IIBrightView XCT , Model Number 882482Philips North America LLCKPS
Z-2010-2019Class IIBrightView X , Model Number 882478Philips North America LLCKPS
Z-2009-2019Class IIBrightView SPECT, Model Number 882480Philips North America LLCKPS
Z-1983-2019Class IIOlympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No...OLYMPUS Corporation of the AmericasFEM
Z-2207-2019Class IIIAssayed Bovine Multi-Sera Level 1, Model No. AL1027Randox Laboratories, LimitedJJY
Z-1961-2019Class IIComprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item...Zimmer GmbHFSM
Z-1960-2019Class IIComprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item...Zimmer GmbHFSM
Z-2237-2019Class IIVAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to...Santanello Surgical LLCJOL
Z-2130-2019Class IIThyroid Collar Oversize, Product Number TS3, Part Numbers RBTS3-R, RETS3-R, RLTS3-R...Burlington Medical LLCEAJ
Z-2129-2019Class IIPorta Shield, Product Number Porta Shield, Part Numbers PTS2, PTS3, PTS4 Product...Burlington Medical LLCEAJ
Z-2128-2019Class IIHood, Product Number Hood, Part Numbers HOOD1, HOOD2 Product Usage: Products are...Burlington Medical LLCEAJ
Z-2127-2019Class IICap, Product Number Cap, Part Numbers CAP1, CAP2 Product Usage: Products are designed to...Burlington Medical LLCEAJ
Z-2126-2019Class IIHalf Apron, Product Number Half Apron, Part Numbers REHALF*, REHALF3 Product...Burlington Medical LLCEAJ
Z-2125-2019Class IIFront/Back Apron with Stretch Velcro Closure, Product Number EURO, Part Numbers...Burlington Medical LLCEAJ
Z-2124-2019Class IIFrontal Apron with Quick Drop Velcro Closure (no elastic), Product Number 401, Part...Burlington Medical LLCEAJ
Z-1956-2019Class ISheridan Endotracheal Tube contained inside Centurion kit code TC7855.Centurion Medical Products, LPBTR
Z-2123-2019Class IISleeve, Product Number Sleeve, Part Numbers RESL, SL 3 L, SL 3 M, SL 3 S, L 3 X, SL 3 XS...Burlington Medical LLCEAJ
Z-2122-2019Class IIThyroid Collar, Buckle Closure, Product Number TS4, Part Numbers RBTS4-R, RBTS4-T2T...Burlington Medical LLCEAJ
Z-2121-2019Class IIThyroid Collar, Velcro Closure, Product Number TS2, Part Numbers RBTS2-R, RETS2-R...Burlington Medical LLCEAJ
Z-2120-2019Class II1 pc Full Wrap Back Relief Apron, Product Number B52 Front & Back Apron, Part Numbers...Burlington Medical LLCEAJ
Z-2119-2019Class IIThyroid Collar, Magnetic Closure, Product Number TS5, Part Numbers RBTS5-R, RBTS5-T2T...Burlington Medical LLCEAJ
Z-2118-2019Class IIKilt, Single Item, Product Number Kilt, Part Numbers ECREKILTF, ECREKILTXLF, REKILTA...Burlington Medical LLCEAJ
Z-2117-2019Class IIPeak Vest, Single Item, Product Number PVest, Part Numbers REPVEST*M, SEPVESTE...Burlington Medical LLCEAJ
Z-2116-2019Class II2 pc Full Wrap Vest & Kilt Back-Saver , Product Number PVK, Part Numbers REPVK*F...Burlington Medical LLCEAJ
Z-2115-2019Class IIOverlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M...Burlington Medical LLCEAJ
Z-2114-2019Class II2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVK*F...Burlington Medical LLCEAJ
Z-2113-2019Class IIVest, Single Item, Product Number Vest, Part Numbers ECREVESTD, ECREVESTF, ECREVESTXLF...Burlington Medical LLCEAJ
Z-2112-2019Class II2 pc Full Wrap Vest & Kilt, Product Number VK, Part Numbers ECREVKA, ECREVKB, ECREVKC...Burlington Medical LLCEAJ
Z-2111-2019Class II1 pc Full Wrap Support Belt Apron, Product Number F111, Part Numbers MTREF111*F...Burlington Medical LLCEAJ
Z-2110-2019Class IIFrontal Quick Drop OR Apron, Product Number 601, Part Numbers ECRE601A, ECRE601B...Burlington Medical LLCEAJ
Z-2109-2019Class IIFrontal Support Belt Apron, Product Number F-15, Part Numbers REF15*F, REF15*M, REF15B...Burlington Medical LLCEAJ
Z-2108-2019Class IIFrontal Apron Velcro Closure, Product Number F-17, Part Numbers REF17A, REF17B, REF17C...Burlington Medical LLCEAJ
Z-2107-2019Class IIFrontal Stretch Buckle Closure Apron, Product Number A-10, Part Numbers REA10A, REA10B...Burlington Medical LLCEAJ
Z-2158-2019Class IIIHenry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number...Polymer Technology SystemsCHH
Z-2157-2019Class IIIPTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number...Polymer Technology SystemsCHH
Z-1923-2019Class IIPhilips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A...Philips North America LLCMKJ
Z-0867-2021Class IIOsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot...Skeletal Kinetics, LLCGXP
Z-0866-2021Class IIOsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number...Skeletal Kinetics, LLCGXP
Z-2410-2019Class IIDRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human...DRG Instruments GmbHJLS
Z-1905-2019Class IISiemens Artis pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000Siemens Medical Solutions USA, Inc.OWB
Z-1904-2019Class IISiemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model Number...Siemens Medical Solutions USA, Inc.OWB
Z-1903-2019Class IISiemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model Number...Siemens Medical Solutions USA, Inc.OWB
Z-1902-2019Class IISiemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System Model Number...Siemens Medical Solutions USA, Inc.OWB
Z-1901-2019Class IISiemens Artis Q zeego ---Interventional Fluoroscopic X-Ray System Model Number: 10848283Siemens Medical Solutions USA, Inc.OWB
Z-1900-2019Class IISiemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282Siemens Medical Solutions USA, Inc.OWB